{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211890"
        ],
        "brand_name": [
          "IBUPROFEN AND FAMOTIDINE"
        ],
        "generic_name": [
          "IBUPROFEN AND FAMOTIDINE"
        ],
        "manufacturer_name": [
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "67877-626"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IBUPROFEN",
          "FAMOTIDINE"
        ],
        "rxcui": [
          "1100066"
        ],
        "spl_id": [
          "5107e958-bc99-4832-931e-4c47e25ec6eb"
        ],
        "spl_set_id": [
          "4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e"
        ],
        "package_ndc": [
          "67877-626-90",
          "67877-626-01",
          "67877-626-05",
          "67877-626-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367877626901",
          "0367877626062"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722",
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]",
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]",
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "WK2XYI10QM",
          "5QZO15J2Z8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93701",
      "recalling_firm": "Ascend Laboratories, LLC",
      "address_1": "339 Jefferson Rd Ste 101",
      "address_2": "N/A",
      "postal_code": "07054-3707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0237-2024",
      "product_description": "Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90",
      "product_quantity": "3,288 bottles",
      "reason_for_recall": "Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.",
      "recall_initiation_date": "20231229",
      "center_classification_date": "20240117",
      "report_date": "20240124",
      "code_info": "23140190, Exp. Date 12/31/2024"
    }
  ]
}